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StrokePhase 4ASPIRE-AFNCT03968393

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

A Phase 4 study testing Non-vitamin K oral anticoagulant (NOAC) in people with Stroke and Atrial Fibrillation, run by Population Health Research Institute at 105 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Stroke, Atrial Fibrillation
What is being tested?
Non-vitamin K oral anticoagulant (NOAC)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,270 participants
Where
105 sitesin 18 countries
Study dates
14 Jun 2019to Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have ≥1 episode of clinically important AFOTS during any of the following conditions:
  • noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
  • noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
  • acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator;
  • sinus rhythm at the time of randomization;
  • any of the following high-risk criteria:
Show all 10Show fewer
  • age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
  • age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
  • age ≥75 years.;
  • provide written informed consent

Who cannot join

  • any cardiac diagnosis as the primary reason for hospital admission;
  • history of documented chronic AF prior to noncardiac surgery;
  • need for long-term systemic anticoagulation;
  • ongoing need for long-term dual antiplatelet treatment;
  • contraindication to oral anticoagulation;
  • severe renal insufficiency (CrCl <20 ml/min);
Show all 15Show fewer
  • severe liver cirrhosis (i.e., Child-Pugh Class C)
  • acute stroke in the past 14 days;
  • underwent cardiac surgery in the past 35 days;
  • history of nontraumatic intracranial, intraocular, or spinal bleeding;
  • hemorrhagic disorder or bleeding diathesis;
  • expected to be non-compliant with follow-up and/or study medications;
  • known life expectancy less than 1 year due to concomitant disease;
  • women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
  • previously enrolled in the trial

Trial locations and contacts

105 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Cassie McDonald contact

1-905-594-0560

aspireaf@phri.ca

105 sites in 18 countries

Canada24 sites, 24 recruiting

  • Foothills Hospital

    Calgary, Alberta, T2N 2T9

    Shannon Ruzycki, MD

    Recruiting

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

    A. Shekhar Pandey, MD

    Not yet recruiting

  • East Kootenay Regional Hospital

    Cranbrook, British Columbia, V1C 3H9

    Denise Jaworsky, MD

    Not yet recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Finlay McAlister, MD

    Recruiting

  • Halifax Infirmary

    Halifax, Nova Scotia, B3H 3A6

    Kim Styles, MD

    Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Mohamed Panju, MD

    Recruiting

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

    Vikas Tandon, MD

    Recruiting

  • Juravinski Hospital

    Hamilton, Ontario, L8V 1C3

    Ameen Patel, MD

    Recruiting

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

    Stephanie Sibley, MD

    Recruiting

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

    Marko Mrkobrada, MD

    Recruiting

  • Medicine Hat Regional Hospital

    Medicine Hat, Alberta, T1A 4H6

    Herbert Manosalva, MD

    Recruiting

  • Dr.-Georges-L.-Dumont University Hospital Centre

    Moncton, New Brunswick, E1C 2Z3

    Remi LeBlanc, MD

    Not yet recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

    Isabelle Greiss, MD

    Recruiting

  • The Ottawa Hospital General Campus

    Ottawa, Ontario, K1H 8L6

    James Villeneuve, MD

    Recruiting

  • CHU de Quebec Universite Laval

    Québec, Quebec, G1R 2J6

    Sebastien Joncas, MD

    Not yet recruiting

  • Regina General Hospital

    Regina, Saskatchewan, S4P 0W5

    Payam Dehghani, MD

    Recruiting

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

    Michael Prystajecky, MD

    Recruiting

  • Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5H3

    Félix Ayala-Paredes, MD

    Recruiting

  • Niagara Health System - St. Catharine's Site

    St. Catharines, Ontario, L2S 0A9

    Leonard Blair, MD

    Recruiting

  • Fraser Health Authority

    Surrey, British Columbia, V3V 1Z2

    Mark Warwas, MD

    Recruiting

  • Cape Breton University

    Sydney, Nova Scotia, B1M 1A2

    Paul MacDonald, MD

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1N1

    Mihalio Veljovic, MD

    Recruiting

  • Cortelluci Vaughan Hospital

    Vaughan, Ontario, L6A 4Z3

    Courtney Anne Scott, MD

    Recruiting

  • Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

    Sadeesh Srinathan, MD

    Recruiting

Other trials in Canada

Australia14 sites, 14 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Peter Psaltis, MD

    Not yet recruiting

  • Bankstown Hospital

    Bankstown, New South Wales, 2200

    Jens Killian, MD

    Recruiting

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland, 4575

    Nicholas New, MD

    Recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    Jaya Chandrasekhar, MD

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Sanjay Patel, MD

    Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

    David Brieger, MD

    Recruiting

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

    Walter Abhayaratna, MD

    Recruiting

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

    John Atherton, MD

    Not yet recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

    John French, MD

    Not yet recruiting

  • John Hunter Hospital

    Newcastle, New South Wales, 2305

    Aaron Sverdlov, MD

    Recruiting

  • Royal Perth Hospital

    Perth, Western Australia, 6000

    Graham Hillis, MD

    Recruiting

  • Redcliffe Hospital

    Redcliffe, Queensland, 4020

    Patrick Carroll, MD

    Recruiting

  • Northeast Health Wangaratta

    Wangaratta, Victoria, 3677

    Anthony Baird, MD

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Clara Chow, MD

    Recruiting

Other trials in Australia

Netherlands12 sites, 12 recruiting

  • Jeroen Bosch Hospital

    's-Hertogenbosch, 5223

    Jacob Van Eck, MD

    Recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815

    Stefan Timmer, MD

    Recruiting

  • ZiekenhuisGroepTwente (ZGT)

    Almelo, 7609

    Lambertus Pos, MD

    Recruiting

  • Ziekenhuis Amstelland

    Amstelveen, 1186

    Freerk Broeyer, MD

    Recruiting

  • Rijnstate Hospital

    Arnhem, 6815

    Ron Pisters, MD

    Recruiting

  • Amphia Ziekenhuis Breda

    Breda, 4818 CK

    Marco Alings, MD

    Recruiting

  • Deventer Ziekenhuis

    Deventer, 7416

    Ype Tuininga, MD

    Recruiting

  • Hospital Gelderse Vallei

    Ede, 6716

    Thomas Oosterhof, MD

    Recruiting

  • Martini Hospital

    Groningen, 9728

    Robert Tieleman, MD

    Recruiting

  • Franciscus Gasthuis

    Rotterdam, 3045

    Peter Nierop, MD

    Recruiting

  • Ikazia Hospital

    Rotterdam, 3083

    Stieneke Zoet-Nugteren, MD

    Recruiting

  • ETZ Tilburg

    Tilburg, 5022

    Walter Hermans, MD

    Recruiting

Other trials in Netherlands

India10 sites, 10 recruiting

  • Marengo CIMS Hospital

    Ahmedabad, Gujarat, 380060

    Ajay Naik, MD

    Not yet recruiting

  • Govt. T.D. Medical College

    Alappuzha, Kerala, 688005

    Sajikumar Raghavan, MD

    Not yet recruiting

  • NU Hospitals

    Bangalore, Karnataka, 560010

    Pramod Krishnappa, MD

    Recruiting

  • St. John's Medical College Hospital

    Bangalore, 560034

    Joe Cherian, MD

    Recruiting

  • GNRC Medical

    North Guwāhāti, Assam, 781031

    Krishna Chaudra Narczarcy, MD

    Not yet recruiting

  • JIPMER

    Puducherry, 605006

    Adinarayanan Sethurmachandran, MD

    Recruiting

  • Ruby Hall Clinic

    Pune, 411057

    Jagdish Hiremath, MD

    Not yet recruiting

  • Trivandrum Medical

    Thiruvananthapuram, 695011

    Prem Menon, MD

    Recruiting

  • Amala Institute of Medical Sciences

    Thrissur, Kerala, 680555

    Rupesh George, MD

    Recruiting

  • Amala Institute

    Thrissur, Kerala, 680555

    Kishore Puthezhath, MD

    Not yet recruiting

Other trials in India

Argentina7 sites, 7 recruiting

  • Hospital Municipal Chivilcoy

    Chivilcoy, B6620

    Pablo Fernandez, MD

    Recruiting

  • Clinica Coronel Suarez

    Coronel Suárez, Buenos Aires, 7540

    Alberto Caccavo, MD

    Recruiting

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe Province, 2000

    Mariela Rasmussen, MD

    Recruiting

  • Instituto Cardiovascular de Rosario

    Rosario, Santa Fe Province, S2000

    Alejandro Meirino, MD

    Recruiting

  • Centro Integral de Arritmias de Tucuman (CIAT)

    San Miguel de Tucumán, Tucumán Province, 4000

    Maria Cecilia Moris, MD

    Recruiting

  • Sanatorio Cisma

    San Miguel de Tucumán, T4000

    Guillermo Isa Messa, MD

    Recruiting

  • Hospital Privado de Rosario

    Santa Fe, S2000GAP

    Carlos Dumont, MD

    Not yet recruiting

Other trials in Argentina

Spain6 sites, 6 recruiting

  • Hospital de Mar

    Barcelona, Barcelona, 08003

    Sandra Beltran de Heredia Marrodan, MD

    Not yet recruiting

  • Vall d'Hebron Hospital

    Barcelona, Barcelona, 08014

    Montserrat Ribas Ball, MD

    Not yet recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Jose M Guerra, MD

    Recruiting

  • Hospital Mutua de Terrassa

    Barcelona, 08221

    Beatriz Toledano Leon, MD

    Recruiting

  • University Hospital Ramon y Cajal

    Madrid, 28034

    Jesus Alvarez Garcia, MD

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008

    Oscar Alcalde, MD

    Recruiting

Other trials in Spain

Italy5 sites, 5 recruiting

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

    Ferruccio Ravazzoni, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milan, 20162

    Matteo Baroni, MD

    Recruiting

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Giuseppe Ristagno, MD

    Recruiting

  • La Maddalena

    Palermo, 90146

    Salvatore D'Arpa, MD

    Recruiting

  • Piacenza Ospedale

    Piacenza, 29121

    Maria Bolognesi, MD

    Recruiting

Other trials in Italy

Pakistan5 sites, 5 recruiting

  • Maroof International Hospital

    Islamabad, 04412

    Mir Abdul Waheed, MD

    Recruiting

  • Shifa International Hospital

    Islamabad

    Saeed Ullah Shah, MD

    Recruiting

  • Aga Khan University

    Karachi, Sindh, 74000

    Yawer Saeed, MD

    Recruiting

  • Dow Medical University

    Karachi

    Muhammad Tariq Farman, MD

    Recruiting

  • Rehman Medical Institute

    Peshawar, 25000

    Azam Jan, MD

    Recruiting

Other trials in Pakistan

Denmark3 sites, 3 recruiting

  • Aarhus University Hospital

    Aarhus, 8200

    Erik Grove, MD

    Recruiting

  • Hospital South West Jutland - University Hospital of Southern Denmark

    Esbjerg, 6700

    Axel Brandes, MD

    Recruiting

  • Odense University Hospital

    Odense, 5000

    Axel Brandes, MD

    Recruiting

Other trials in Denmark

Nepal3 sites, 3 recruiting

  • Nobel Medical College Teaching Hospital

    Biratnagar, 56700

    Rajesh Nepal, MD

    Recruiting

  • B.P. Koirala Institute of Health Sciences

    Koshi, 56700

    Sanjib Sharma, MD

    Recruiting

  • B and B Hospital

    Lalitpur, 44700

    Rajib Rajbhandari, MD

    Recruiting

Other trials in Nepal

South Korea3 sites, 3 recruiting

  • Korea Univesrity Anam Hospital

    Seoul, 02841

    Jong-Il Choi, MD

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Eue-Keun Choi, MD

    Recruiting

  • Seoul National University Bundang Hospital

    Seoul, 13620

    Il-Young Oh, MD

    Recruiting

Other trials in South Korea

Switzerland3 sites, 3 recruiting

  • University Hospital Basel

    Basel, Basel, 4031

    Philipp Krisai, MD

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen, 9000

    Timur Yurttas, MD

    Recruiting

  • Kantonsspital Winterthur

    Winterthur, 8400

    Michael Osthoff, MD

    Recruiting

Other trials in Switzerland

United States2 sites, 2 recruiting

  • Mcgovern Medical School at University of Texas

    Houston, Texas, 77030

    Sanjana Malviya, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Eric Braunstein, MD

    Recruiting

Other trials in United States

Brazil2 sites, 2 recruiting

  • Instituto do Coração do Hospital das Clínicas da FMUSP

    Cerqueira César, 05403-900

    Carlos Serrano, MD

    Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

    Carisi Polanczyk, MD

    Recruiting

Other trials in Brazil

Sweden2 sites, 2 recruiting

  • Karolinska Institutet Danderyd Hospital

    Danderyd, 18257

    Piotr Sobocinski-Doliwa, MD

    Recruiting

  • Uppsala University

    Uppsala, 751 85

    Claes Held, MD

    Gorav Batra, MD

    Recruiting

Other trials in Sweden

United Kingdom2 sites, 2 recruiting

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

    Michael Shackcloth, MD

    Recruiting

  • Southend Hospital

    Westcliff-on-Sea, SS0 0RY

    James Jegard, MD

    Recruiting

Other trials in United Kingdom

Finland1 site, 1 recruiting

  • Southwest Finland Wellbeing County (VARHA)

    Turku, 20520

    Tuomas Kiviniemi, MD

    Recruiting

Other trials in Finland

Germany1 site, 1 recruiting

  • Universitatsklinikum Leipzig

    Leipzig, 04103

    Rolf Wachter, MD

    Recruiting

Other trials in Germany

About this study

Official title: Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.

Read the detailed description

ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient atrial fibrillation and additional stroke factors occurring transiently with stress. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Being tested
Non-vitamin K oral anticoagulant (NOAC)
Keywords
Transient Atrial Fibrillation, Perioperative Atrial Fibrillation, Non-vitamin K Oral Anticoagulation, Noncardiac Surgery, PROBE Design, Medical Illness, Stress
Medical subject headings
Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-vitamin K oral anticoagulant (NOAC)Drug

    Also called Apixaban, Dabigatran, Edoxaban, Rivaroxaban

    Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.

Study groups in NCT03968393
Study groupRoleWhat they receive
Non-vitamin K oral anticoagulant (NOAC)ExperimentalParticipants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.
Receives: Drug: Non-vitamin K oral anticoagulant (NOAC)
No anticoagulationNo interventionParticipants randomized to the control arm will not be prescribed an oral anticoagulant unless they develop a clear indication for one during follow-up (e.g., recurrent nonoperative AF). They can be newly prescribed or continue taking low dose aspirin or another single antiplatelet agent as per the protocol. This will be decided by the participant's physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Non-hemorrhagic stroke or systemic embolism

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  2. Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Secondary outcomes (8)

  1. Incidence of vascular mortality

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  2. Incidence of non-fatal, non-hemorrhagic stroke

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  3. Incidence of Myocardial infarction

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  4. Incidence of peripheral arterial thrombosis

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  5. Incidence of amputation

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  6. Incidence of symptomatic venous thromboembolism

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  7. Incidence of all-cause stroke

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

  8. Incidence of all-cause mortality

    Measured: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start14 Jun 2019
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, open-label clinical trial with blinded outcome assessment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03968393
Sponsor's protocol ID
2019-ASPIREAF
Other IDs
2023-509142-35-00, 2019-001336-62, 2019, 2023
Acronym
ASPIRE-AF
Status last verified
Jan 2026
First submitted
22 Mar 2019
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Boriani G, Imberti JF, McIntyre WF, Mei DA, Healey JS, Schnabel RB, Svennberg E, Camm AJ, Freedman B. Detection and management of postoperative atrial fibrillation after coronary artery bypass grafting or non-cardiac surgery: a survey by the AF-SCREEN International Collaboration. Intern Emerg Med. 2025 Apr;20(3):739-749. doi: 10.1007/s11739-025-03861-2. Epub 2025 Feb 8.

    PubMed 39921772

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Non-vitamin K oral anticoagulant (NOAC) in people with Stroke and Atrial Fibrillation, run by Population Health Research Institute at 105 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in Canada, Australia, Netherlands, India, Argentina and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cassie McDonald (1-905-594-0560, aspireaf@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Non-hemorrhagic stroke or systemic embolism (time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03968393, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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